Tissue retention systems and methods

ABSTRACT

A tissue retention belt for maintaining tissue in a position that permits access to a body portion of a patient for a medical procedure includes a first anchor zone, a second anchor zone, and a tension zone. The tension zone extends between the first anchor zone and the second anchor zone and defines a tension axis that extends in a direction of loading to be applied to retained tissue. The tension zone may include an auxiliary anchor zone that includes a removable non-adhesive and an adhesive surface configured to adhere to a patient&#39;s skin and provide auxiliary anchoring for maintaining tissue in position.

PRIORITY

This application is a continuation of U.S. application Ser. No.15/977,776, filed May 11, 2018, now U.S. Pat. No. 10,925,792, which isdivisional of U.S. application Ser. No. 15/645,578, filed Jul. 10, 2017,now U.S. Pat. No. 9,993,382, each of which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

This disclosure relates in general to systems and methods for retainingpatient body tissue in a desired position and retaining objects inrelation to the body tissue. More particularly, in some particularimplementations, this disclosure relates to systems and methods forretaining patient body tissue in a displaced position during a medicalprocedure on a patient.

BACKGROUND

The size and constitution of the human body can affect the availabilityand efficiency of medical care that can be provided. For example,adipose tissue, such as a pannus or an abdominal apron on an obesepatient, may completely obscure access to a body region requiring amedical procedure. In cases of excessive adipose tissue, a treatingmedical professional attempting to examine, treat or otherwise accessthe lower abdomen or groin region of the patient may have only limitedvisualization and may have insufficient access to perform procedures.

Some current systems and methods for dealing with tissue, such as thepannus, include having medical staff use their hands to hold the weightof the pannus or other adipose body tissue during the entire procedure,using tape (or tape in conjunction with spray adhesives) to hold thepannus or other adipose tissue, using hooks that secure or grab thepannus or other adipose tissue, and supporting the pannus or adiposetissue with a sheet that may be tied around the patient's abdomen and toa bed side rail or chair. One example of such known techniques includesthe method and apparatus described in U.S. Pat. No. 8,881,732, issued toBlurton et al. on November 2014, entitled “Method and Apparatus forRetention of Adipose Tissue”, and assigned to the same assignee as thepresent disclosure (the '732 patent).

An additional system and method for dealing with tissue includes asheet-like adhesive film that completely covers the patient's skin inthe displaced area. Such a system may have several shortcomingsincluding for example excessive adhesion over the contact area. This maymake the adhesive film difficult to apply. In addition, because the filmmay cover a large area of the body, it may be cumbersome to remove. Anexample of this type of technique is shown and described in U.S. Pat.No. 9,427,222, issued to Galbierz et al. on Aug. 10, 2016, entitled“Retractor/Stabilizer for Excessive and/or Redundant Tissue and Methodof Use”, and assigned to GSquared Medical, LLC.

Accordingly, the above-mentioned conventional systems all haveshortcomings that continue to make medical procedures difficult. Thepresent disclosure overcomes one or more shortcomings in the art.

SUMMARY

It is an object of the present disclosure to provide a tissue retentionbelt and method for maintaining tissue in a position that permits accessto a body portion of a patient for a medical procedure.

Some examples of the tissue retention belt may include a first anchorzone comprising an adhesive surface configured to adhere to a patient'sskin, and may include a second anchor zone spaced from the first anchorzone, the second anchor zone configured to attach to an inanimate objector the patient. A tension zone may be integrated with the first anchorzone and may extend between the first anchor zone and the second anchorzone. The tension zone may define a tension axis that extends in adirection of loading to be applied to retained tissue. The tension zonemay include an auxiliary anchor zone that includes a removablenon-adhesive outer surface that may cover an adhesive surface configuredto adhere to a patient's skin and provide auxiliary anchoring formaintaining tissue in position.

In some aspects, the adhesive surface of the auxiliary anchor zone has adifferent bond strength than the adhesive surface of the first zone. Insome aspects, the first anchor zone, the second anchor zone, and thetension zone are aligned along and intersected by the tension axis. Insome aspects, the tension zone comprises a non-adhesive region adjacentthe auxiliary anchor zone. In some aspects, the auxiliary anchor zone isdisposed adjacent the first anchor zone and between the first and secondanchor zones. In some aspects, one of the first anchor zone, secondanchor zone, and the tension zone comprises a surgical film. In someaspects, the second anchor zone comprises one of a hook material or aloop material, and the tension zone comprises the other of a hookmaterial or a loop material. The second anchor zone and the tension zonemay be selectively attachable about an anchoring structure using hookand loop fastening. In some aspects, the tension zone comprises aplurality of auxiliary anchor zones disposed along the tension zone,each of the plurality of auxiliary anchor zones comprising anindependently removable non-adhesive outer surface. In some aspects, theremovable non-adhesive outer surface of one of the plurality of theauxiliary anchor zones is separated by perforations from the removablenon-adhesive outer surface of another of the plurality of the auxiliaryanchor zones. In some aspects, the tension zone is integral with thefirst anchor zone and affixed to the second anchor zone. In someaspects, the tension zone comprises a patterned adhesive for adhesion toskin of the patient. In some aspects, the patterned adhesive comprisesalternating adhesive and non-adhesive portions. In some aspects, theinanimate object is a mechanical structure disposed adjacent to thepatient. In some aspects, the first anchor zone is sized to carry a loadof at least 5 lbs when adhered to the patient's skin. In some aspects,the first anchor zone, the second anchor zone, and the auxiliary anchorzone comprise a monolithic layer.

Additional examples of the tissue retention belt may include a firstanchor zone comprising an adhesive surface configured to adhere to apatient's skin, and may include a tension zone extending from the firstanchor zone along a tension axis that extends in a direction of loadingto be applied to retained tissue. The tension zone may include anauxiliary anchor zone adjacent the first anchor zone, and auxiliaryanchor zone may include a removable non-adhesive outer surface coveringan adhesive surface configured to adhere to a patient's skin. A secondanchor zone may extend from the tension zone and be disposed at alocation spaced along the tension zone apart from the first anchor zoneand apart from the auxiliary anchor zone.

In some aspects, the tension zone comprises a non-adhesive portionadjacent the auxiliary anchor zone, the non-adhesive portion beingarranged to contact the patient's skin. In some aspects, the firstanchor zone and the tension zone comprise a monolithic layer. In someaspects, the first anchor zone is an adhesive pad configured to adhereto a patient's skin and the tension zone is selectively attachable tothe adhesive pad. In some aspects, the second anchor zone is an adhesivepad configured to adhere to a patient's skin and the tension zone isselectively attachable to the second anchor zone. In some aspects, thefirst anchor zone, the second anchor zone, and the tension zone are allaligned and intersected by the tension axis. In some aspects, theadhesive surface of the auxiliary anchor zone has a lower bond strengththan the adhesive surface of the first zone. In some aspects, thetension zone comprises a non-adhesive region adjacent the auxiliaryanchor zone and disposed between the auxiliary anchor zone and thesecond anchor zone. In some aspects, the second anchor zone comprisesone of a hook material or a loop material and the tension zone comprisesthe other of a hook material or a loop material, the second anchor zoneand the tension zone being selectively attachable about an anchoringstructure using hook and loop fastening. In some aspects, the tensionzone comprises a plurality of auxiliary anchor zones disposed along thetension zone, each of the plurality of auxiliary anchor zones comprisinga removable non-adhesive outer surface.

Some examples of methods may include providing a tissue retention beltas described herein, exposing the adhesive surface of the first anchorzone by removing a backing material, and adhesively adhering the firstanchor zone to a patient's skin at a first skin location and attachingthe second anchor zone at an anchor location spaced apart from the firstskin location. The first and second anchor zones may be tautly connectedvia the tension zone along a tension axis that extends in a direction ofapplied loading.

The method also may include exposing the adhesive surface of theauxiliary anchor zone by removing the non-adhesive outer surface of theauxiliary anchor zone and adhesively adhering the adhesive surface ofthe auxiliary anchor zone to the patient to distribute skin loading ontoboth the first anchor zone and the auxiliary anchor zone. The methodalso may include revising the fit of the tissue retention belt byunattaching the second anchor zone prior to exposing the adhesive of theauxiliary anchor zone and after adhesively adhering the auxiliary anchorzone, reattaching the second anchor zone. The method also may includeexposing the adhesive of the auxiliary anchor zone and adhesivelyadhering the auxiliary anchor zone prior to attaching the second anchorzone at the anchor location spaced apart from the first skin location.The method also may include looping the second anchor zone around aphysical structure and attaching the second anchor zone to itself.

Further objects, forms, implementations, aspects, features, benefits,and advantages of the present disclosure shall become apparent from thedetailed drawings and descriptions provided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an exemplary tissue retention systemaccording to an exemplary implementation of the present disclosure.

FIG. 1A is an illustration of a cross-sectional view taken along lines1A-1A in FIG. 1 of the exemplary tissue retention system according to anexemplary implementation.

FIG. 2 is an illustration of an exemplary tissue retention belt of thetissue retention system having an auxiliary anchor zone according to anexemplary implementation of the present disclosure.

FIG. 3 is an illustration of an exemplary tissue retention belt of thetissue retention system having an exposed adhesive layer according to anexemplary implementation of the present disclosure.

FIG. 3A is an illustration of a cross-sectional view taken along lines3A-3A in FIG. 3 of the exemplary tissue retention belt according to anexemplary implementation.

FIG. 4 is an illustration of an obese patient showing the pannus orabdominal apron with the tissue retention system according to anexemplary implementation of the present disclosure.

FIG. 5 is an illustration of the obese patient with the pannus orabdominal apron maintained in a displaced position using the tissueretention system according to an exemplary implementation.

FIG. 6 is an illustration of a side view of an obese patient with thepannus or abdominal apron maintained in a displaced position using amain anchor zone.

FIG. 7 is an illustration of a side view of an obese patient with thepannus or abdominal apron maintained in a displaced position using boththe main anchor zone and the auxiliary anchor zone.

FIG. 8 is an illustration of a perspective view of another exemplarytissue retention belt having an auxiliary anchor zone according to anexemplary implementation of the present disclosure.

FIG. 9 is an illustration of a side view of another exemplary tissueretention belt having an auxiliary anchor zone according to an exemplaryimplementation of the present disclosure.

FIG. 10 is an illustration of a side view of another exemplary tissueretention belt having an auxiliary anchor zone according to an exemplaryimplementation of the present disclosure.

FIG. 11 is an illustration of a side view of another exemplary tissueretention belt having an auxiliary anchor zone according to an exemplaryimplementation of the present disclosure.

FIG. 12 is an illustration of a side view of another exemplary tissueretention belt having an auxiliary anchor zone according to an exemplaryimplementation of the present disclosure.

FIG. 13 is an illustration of an adhesive pattern of an anchor zoneaccording to an exemplary implementation of the present disclosure

FIG. 14 is an illustration of a tissue retention belt roll according toan exemplary implementation of the present disclosure

FIG. 15 is a flow chart illustrating a method of using a tissueretention system according to an exemplary implementation of the presentdisclosure.

FIG. 16 is a flow chart illustrating a method of using a tissueretention system according to an exemplary implementation of the presentdisclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to certain implementations, orexamples, illustrated in the drawings and specific language will be usedto describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended. Anyalterations and further modifications in the described implementations,and any further applications of the principles of the invention asdescribed herein are contemplated as would normally occur to one skilledin the art to which the invention relates.

Adipose tissue may hinder access to regions of the patient's body duringroutine or non-routine healthcare treatment. For example, in someinstances, adipose tissue may detrimentally affect visualization orother access to regions of the patient's body to perform procedures,such as, for example, panniculectomies, to treat panniculitis, generalwound care, femoral catheterization, tracheal intubation, cesareansections, hysterectomies, among other medical procedures.

The tissue retention system disclosed herein includes a tissue retentionbelt that may be used to maintain adipose tissue in a position thatprovides better access to patient body regions requiring treatment. Forexample, it may be used to displace or secure adipose tissue, such asthe abdominal apron or pannus, out of the lower abdomen or groin regionduring child birthing to provide better visualization and easier accessto an attending health care provider.

Skin is composed of multiple layers. The main layers comprise theepidermis layer, the dermis layer, and subcutaneous tissue. Theepidermis layer comprises sublayers including stratum corneum, stratumludidum (not present in thin skin, only thick, hairless skin of palms &soles), stratum granulosum, stratum spinosum, and stratum germinativum.The tissue retention system disclosed herein is a non-penetratingsolution that adheres to the epidermal layers of the skin withoutadhering to the dermis or subcutaneous tissue to displace adiposetissue. Further, certain aspects do so without penetrating or pinchingtissue to obtain skin anchorage, unlike hooks or other skin grippingsystems, which can damage the skin. Instead, it is flexible enough toconform to natural curves of the anatomy, without major tissuedeformation or penetration. It may be desirable to employ a tissueretention system having one or more auxiliary anchor zones that permitsa healthcare provider to customize the adhesion area of the belt to thepatient. Doing so may allow the health care provider to avoid excessiveover adhesion, while still providing sufficient adhesion to safely andproperly maintain the tissue in a desired position. Excessive overadhesion may make separation of the tissue retention belt from the skintedious, painful and cumbersome. Excessive under adhesion may result inoverly heavy loads across small skin areas, resulting in damage to theskin or delamination of skin layers.

While the emphasis of this discussion is on retention of the pannus forchild birthing, it is noted that the present tissue retention system hasapplication in displacing or maintaining adipose tissue of other bodyregions for many different medical applications, only some of which arediscussed herein. Alternative uses may be shown in the '732 patent,which is incorporated herein in its entirety. Further, while movementand retention of adipose tissue is illustrated for surgical access, itwill be appreciated that adipose tissue may be mobilized for otherreasons, such as, for example, restraining tissue (offloading weight) onthe chest area that inhibits breathing in some patient positions.

Turning now to FIGS. 1, 1A, 2, 3, and 3A, the tissue retention system,referenced herein by the numeral 100, includes a tissue retention belt102 and a separable anchor pad 104. As discussed in greater detailbelow, the tissue retention belt 102 is configured to attach directly toa patient's skin, such as adjacent adipose tissue. The tissue retentionbelt 102 includes a facing body side 106 and an opposing facing awayside 108. In use, the facing body side 106 is in contact with thepatient. The tissue retention belt 102 also includes a primary anchorzone 110 at a distal region, a tension zone 112, and a secondary anchorzone 114 at a proximal region.

As used herein, the “primary anchor zone” refers to an anchor attachableto adjacent adipose tissue, and the “secondary anchor zone” refers to ananchor attachable at a location spaced apart from the primary anchorzone. As will become apparent from the disclosure herein, the secondaryanchor zone may be attachable to the anchor pad 104, patient's skin, amechanical structure or other inanimate object such as a portion of thesurgical bed, additional portions of the tension zone 112, or otherlocations.

FIG. 1 shows a top view of the tissue retention system 100; FIG. 1Ashows a cross-sectional view of the tissue retention system 100 takenalong lines 1A-1A in FIG. 1; FIG. 2 shows a bottom view of the tissueretention belt 102 with a removable backing; FIG. 3 shows a bottom viewof the tissue retention belt 102 without a portion of the removablebacking; FIG. 3A shows a cross-sectional view of the tissue retentionbelt 102 taken along lines 3A-3A in FIG. 3.

In the implementation shown, and as best shown in FIGS. 3 and 3A, theprimary anchor zone 110 of the tissue retention belt 102 includes a bodyportion 120 which serves as a stabilizing backing for a biocompatibleadhesive layer 122. The body portion 120 may be a film, a fabric, awoven material, a mesh material, a matting, paper, a polymer such as aplastic, or any flexible yet suitable material. The adhesive layer 122is configured to adhere directly to a patient's skin or an inanimatesurface. Some implementations are formed of a polyurethane film with apolyacrylate adhesive. In some implementations, the adhesive of theadhesive layer 122 is configured to easily release from the patient'sskin with minimal damage or soreness after a medical procedure iscomplete. In some implementations, prior to use, the adhesive layer 122faces a non-stick removable backing 121 (FIG. 2) that can be peeled awayto reveal the adhesive layer 122 on the body portion 120. FIG. 2 showsthe tissue retention belt 102 with the removable backing 121 in place,and FIGS. 3 and 3A show the tissue retention belt 102 without theremovable backing in place. The removable backing 121 is a protectivelayer that covers the adhesive layer 122 of the primary anchor zone 110.The removable backing 121 may be any material, such as a non-stickplastic material, that may be left attached to the adhesive layer 122 toprevent the adhesive layer 122 from coming inadvertently into contactwith or adhering to the patient's body. The removable backing 121 may beconfigured to be cut or sliced, punctured, perforated, or penetratedwith an instrument or device. The adhesive layer 122 may be formed of abiocompatible adhesive that may secure the primary anchor zone 110 tothe patient's skin. Examples of suitable adhesives include, withoutlimitation, acrylic adhesives, silicone based adhesives, urethaneadhesives, synthetic or natural rubber adhesives, among others.

The tension zone 112 extends from a location directly adjacent theprimary anchor zone 110. In this implementation, the tension zone 112extends the full distance between the primary anchor zone 110 and thesecondary anchor zone 114. With reference to FIG. 3, the tension zone112 includes an auxiliary anchor zone 130 and a non-adhering contactregion 132. The tension zone 112 defines tension axis 134. Since thetension zone 112 is disposed between the primary anchor zone 110 and thesecondary anchor zone 114, the tension axis 134 extends between and alsointersects the primary anchor zone 110 and the secondary anchor zone114. As will become apparent by this disclosure, the tension axis 134extends in a direction of loading to be applied to retained tissue.

The auxiliary anchor zone 130 includes a body portion 140 and anadhesive layer 142. In addition, the auxiliary anchor zone 130 includesa removable backing 144. In some implementations, the body portion 140may be integral with and an extension of the body portion 120 from theprimary anchor zone 110, thereby forming a monolithic layer. In otherimplementations, the body portion 140 may be permanently affixed to thebody portion 120. For example, the body portion 140 and the body portion120 may be permanently affixed by being sewn together, welded together,glued to each other, or otherwise connected in a way that makes themunseparable. In a similar manner, the adhesive layer 142 of the tensionzone 112 may be a continuous extension from the adhesive layer 122 ofthe primary anchor zone 110. In other implementations, the adhesivelayers 122, 142, are substantially adjacent to each other and may be ofdiffering adhesive strength so that they each support each other duringvarious loading situations to distribute any applied load over both theprimary anchor zone 110 and the auxiliary anchor zone 130. In theimplementation shown, the removable backing 144 is a protective layerthat covers the adhesive layer 142 of the auxiliary anchor zone 130. Itmay be formed of the material described above with reference toremovable backing 121. When needed, the removable backing 144 may beconfigured to be removed from the adhesive layer 142 to expose theadhesive layer 142 so that it can contact and adhere to the patient'sskin. Accordingly, the removable backing 144 may be utilized by ahealthcare provider to customize the size of the adhesive area of thetissue retention belt 102. The removable backing 144 may be formed of abiocompatible backing material utilized in the medical industry.

In the exemplary embodiment shown, the removable backing 144 includes agraspable tab 146 that extends from an edge of the adhesive layer 142.The graspable tab 146 is attached to the removable backing 144 in amanner enabling the health care provider to remove the removable backing144 from the adhesive layer 142 by pulling the graspable tab 146. Insome implementations, the graspable tab 146 may simply be an extensionof the removable backing 144. In the implementation shown, the graspabletab 146 is disposed at a location of the auxiliary anchor zone 130closest to the secondary anchor zone 114. However, the graspable tab 146may be disposed at any point about the auxiliary anchor zone thatenables a healthcare provider to remove the removable backing 144 fromthe auxiliary anchor zone 130.

The non-adhering contact region 132 of the tension zone 112 extendsbetween the auxiliary anchor zone 130 and the secondary anchor zone 114.This portion of the tension zone 112 may be formed to not adhere to thepatient's body. Accordingly, even when the auxiliary anchor zone 130 isused to adhere to a patient, the non-adhering contact region 132provides a nonstick zone that allows adjustment, pulling, and shiftingof the proximal end and the secondary anchor zone 114 of the tissueretention belt 102. In some implementations, the non-adhering contactregion 132 is formed as a skin contact area that may include for examplea layer of hook material or loop material, an adhesive backer, or insome implementations, no adhesive at all.

FIG. 3A shows a cross-sectional view of the non-adhering contact region132. In the implementation shown, the non-adhering contact region 132 isformed of a body portion 150 that extends from the auxiliary anchor zone130 toward the secondary anchor zone 114. In the exemplary embodimentshown, the body portion 150 may be integral with an extension of thebody portion 140 that forms a part of the auxiliary anchor zone 130,thereby forming a monolithic layer therewith. In some implementations,the body portion 150 may be integral with and an extension of the bodyportions 120 and 140, thereby forming a monolithic layer therewith. Inother implementations, the body portion 150 may be permanently affixedto the auxiliary anchor zone by using any of the example methodsdescribed herein including, without limitation, sewing, ultrasonicwelding, adhering, and others.

The non-adhering contact region 132 in the implementation shown is anadhesion free zone. In other implementations, the non-adhering contactregion 132 may be covered with one or more alternative layers ofmaterial. For example, some implementations may include a layer of hookor loop material along the non-adhering contact region. This may includea loop material with soft fiber loops that are gentle on the skin. Otherimplementations include an adhesive layer that is covered in a mannerpreventing the adhesive layer from contacting the skin of the patient.Some implementations include an adhesive backer covering an adhesivelayer in the non-adhering contact region 132.

The secondary anchor zone 114 is disposed at the proximal end of thetissue retention belt 102. The secondary anchor zone 114 may be arrangedto adhere to the anchor pad 104 in FIG. 1 or adhere to another surfaceabout the patient. In some examples, the secondary anchor zone 114 maybe located to attach to a mechanical structure or other inanimateobject, such as a bedframe, a bed rail, or other anchor location. Insome examples, the secondary anchor zone 114 may be located to attach tothe patient itself.

With reference to FIG. 3A, the secondary anchor zone 114 is fixedlyattached directly adjacent the non-adhering contact region 132. In someimplementations, the secondary anchor zone 114 may include one or morelayers of material integrally formed with the tension zone 112 and/orthe primary anchor zone 110, such that one or more monolithic layersform a part of at least the secondary anchor zone 114 and the tensionzone. In this implementation, the secondary anchor zone 114 includes abody portion 160, an attachment surface 162, and a fastening feature 164formed on the attachment surface 162. Here the fastening feature 164 isa plurality of generally soft fiber loops on the attachment surface 162.In some examples, the fastening feature 164 is a hook material insteadof a loop material. Other implementations have different fasteningfeatures. As will be described herein, some implementations employ anadhesive layer that makes up the attachment surface 162 and thefastening feature 164. The adhesive layer may attach to the separableanchor pad 104 of FIG. 1. In some implementations, the fastening feature164, whether a hook, loop, adhesive, or other material, is included oversubstantially the entire attachment surface 162 of the secondary anchorzone 114. Although many types of materials may be used, in an example,the body portion 160 may be formed of a polyethylene material and theattachment surface 162 may be formed of a nylon material. In theexemplary embodiment shown, the body portion 160 may be integral with anextension of the body portion 150 forming a part of the tension zone116, thereby forming a monolithic layer therewith. In someimplementations, the body portion 160 may be integral with and anextension of the body portions 120, 140, and 150, thereby forming amonolithic layer therewith.

The tissue retention belt 102 is at least partially flexible andconfigured to conform to contours of the patient's body shape. Forexample, the tissue retention belt 102 may be sufficiently flexible toconform about a patient's curved abdominal apron or along a patient'scurved thigh or conform to other portions of a patient's body. In anexemplary embodiment, tissue retention belt 102 is fully flexible overits overall length.

In FIGS. 2 and 3, a cut 155 in the backing material separates theremovable backing 121 from the removable backing 144. The cut 155 may bea die cut that enables a health care provider to expose the adhesivelayer 122 of the primary anchor zone 110 without exposing the auxiliaryanchor zone 130. In some implementations, the cut 155 extends completelythrough the removable backing layer and the adhesive layer. In otherimplementations, the cut 155 is a line of perforations. In such animplementation, the health care provider may tear along the perforationsto remove the removable backing material 121 from the primary anchorzone 110 without removing the backing material 144 of the auxiliaryanchor zone 130.

In the implementation shown, the tissue retention belt 102 includes amaximum width W₁, a minimum width W₂, and an overall length L₁. In theimplementation shown, the maximum width is located at the primary anchorzone 110, while the minimum width W₂ is measured along the tension zone112. Accordingly, the tissue retention belt 102 includes a relativelywider primary anchor zone 110 and a relatively narrower tension zone112. In this implementation, the secondary anchor zone 114 has about thesame width as the tension zone 112. However, in other implementationsthe secondary anchor zone 114 may have a width greater than or smallerthan the width of the tension zone 112. Though the dimensions of thetissue retention belt 102 may vary, in some implementations the maximumand minimum widths W₁, W₂ are between about 1 and 20 inches, althoughother widths, both larger and smaller are contemplated. The longitudinallength L₁ may be selected based on the patient and the anticipatedanchoring locations. However, in some embodiments, the longitudinallength L₁ may be within a range of about 24 to 72 inches, although otherlengths, both larger and smaller, are contemplated. In some examples,the longitudinal length L₁ may be within a range of about 48 to 72inches.

In this embodiment, the primary anchor zone 110 has a circular shape,forming a bulbous distal end of the tissue retention belt 102. Theprimary anchor zone 110 may be formed to have an area sufficiently largeto provide satisfactory anchoring without tissue damage in mostcircumstances. Some examples of the first anchor zone are sized with anarea to carry a load of at least 5 lbs when adhered to the patient'sskin. In some examples, the primary anchor zone 110 may have an area ina range of about 20 to 200 square inches. Other dimensions, both largerand smaller, are also contemplated. In examples that are relativelycircular, as is shown in FIGS. 1-3, the primary anchor zone 110 may havea radius in the range of about 2 to 8 inches, although other radiuses,both larger and smaller are contemplated. Although shown as relativelycircular, primary anchor zones in other embodiments include othershapes. For example, the primary anchor zone 110 may be relativelysquare, rectangular, oval, kidney shaped, or may have other shapes. Insome implementations, the primary anchor zone 110 is sized with a widthequal to a width of the tension zone 112. Accordingly, in theseembodiments, the primary anchor zone 110 may appear as a portion of astrap with a relatively constant width of parallel edges forming thetissue retention belt 102 over its overall length L₁.

The tension zone 112 extends from the primary anchor zone 110 to thesecondary anchor zone 114, and may have a length L₂ within a range ofabout 12 to 64 inches, although larger and smaller lengths arecontemplated. The tension zone 112 may have a width matching the minimumwidth W₂ or may have a width falling between the minimum width W₂ andthe maximum width W₁. In some embodiments, the minimum width W₂ and themaximum width W₁ are equal. In some embodiments, the width of thetension zone 112 is in the range of about 1 to 6 inches, while in otherembodiments, the width of the tension zone 112 is in the range of about1 to 3 inches. Other widths are also contemplated.

In the implementation shown, the secondary anchor zone 114 has the samewidth as and is an extension of the tension zone 112. The secondaryanchor zone 114 may be disposed at a proximal end of the tissueretention belt 102 or may be disposed distal of the proximal end. Thelocation of the secondary anchor zone 114 may be defined simply by theportion of the tissue retention belt 102 that overlaps and connects withthe separable anchor pad 104 in FIG. 1. In some implementations,secondary anchor zone 114 may be formed of a material attachable to theseparable anchor pad 104, while in other implementations, the secondaryanchor zone 114 may be formed to fold or bend and attach to itself. Insome implementations, the secondary anchor zone 114 comprises anadhesive that attaches directly to the patient or an inanimate object.In such implementations, the separable anchor pad 104 may be notutilized. The secondary anchor zone 114 may have a width that matchesthe width of the tension zone 112. Accordingly, it may be in the rangeof about 1 to 6 inches in some embodiments, while in other embodimentsit may be in the range of about 1 to 3 inches. In some implementations,the secondary anchor zone 114 may be sized and shaped to mimic theprimary anchor zone 110. For example, in some implementations, thesecondary anchor zone 114 is bulbous shaped and has a relativelycircular adhesion zone. Accordingly, the widths and sizes describedherein relating to the primary anchor zone 110 may also apply to thesecondary anchor zone 114.

Material properties and structure of the tension zone 112 determine itsyield strength or elasticity. For example, the width, thickness, andmaterial of the body portion 140, (in combination with the other layersof the tension zone 112) may be selected to provide desired yield orelasticity characteristics. Furthermore, these may be selected tocooperate with the adhesive and size of the primary anchor zone 110 inthe secondary anchor zone 114 so that, in use, the tension zone 112stretches before the primary anchor zone 110 begins to detach from thepatient's skin or before the secondary anchor zone 114 detaches orbefore the separable anchor pad 104 begins to detach from the patient'sskin. In the following descriptions, the hook and loop fastener isdesigned to hold the described shear load without failure. For exampleonly, in implementations where the primary anchor zone 110 has adhesiveproperties such that it begins to detach from the patient's skin at peelloads of three oz/inch width at 180 degree peel, then the tension zone112 may be designed to elongate either elastically or in-elastically atloads less than three oz/inch width applied at 180 degrees. Accordingly,in implementations having a primary anchor zone width of 5 inches, loadsof 15 oz at 180 degrees are required to peel the anchor pad at 180degrees. This example however, is not limiting as it is contemplatedthat other levels of adhesion or bond strength also may be implemented.In some implementations, an additional safety factor may be included,such that the body portion 140 (or the entire tension zone 112) beginsto stretch at, for example, loads less than 90% of the peel load. Inother words, using the example above, the safety factor may be appliedso that the body portion 140 begins to stretch at loads less than 90% of15 oz at 180 degree peel or equivalently 13.5 oz. The safety factor maybe 80%, 60%, or other factor between 0% and 100%.

In other implementations, the tension zone 112 elongates eitherelastically or in-elastically before the primary anchor zone 110 or thesecondary anchor zone 114 begins to damage the patient's skin, therebyavoiding blistering, tearing or separation of skin layers, or otherdamage that may occur by inadvertent overloading. As an example, if skindamage occurs under shear loads of 40 oz/in² of skin and the primaryanchor zone 110 has an area of 12 in², then the tension zone 112 may beformed so that the body portion 140 (or the entire tension zone 112)stretches at loads less than 480 oz or equivalently at loads less than30 lb. In some implementations, an additional safety factor may beincluded, such that the body portion 140 (or the entire tension zone112) begins to stretch at, for example, loads less than 90% of theanchor pad area multiplied by the skin shear force. In other words,using the example above, the safety factor may be applied so that thebody portion 140 begins to stretch at loads less than 90% of 12 in²multiplied by 40 lbs/in², equaling 432 oz or equivalently 27 lb. Thesafety factor may be 80%, 60%, or other factor between 0% and 100%. Theload value at which skin damage occurs, or at which skin integrity iscompromised, may vary depending on the age of the patient, the locationof the anchor pad on the body, the angle of the force applied, theamount of time the force is applied, the dwell time of the adhesive,skin properties such as porosity and moistness, and other factors. It iscontemplated that the tension zone may have properties that permit it toelastically or in-elastically elongate at loads of about 60 lbs in someimplementations. Elongation is considered to have occurred when thetension zone 112 stretches more than 2% of the length between anchoringpoints. In some implementations, the tension zone 112 elongates at loadsof about 40 lbs, while in other implementations, at loads of about 30lbs. In yet other implementations, it elongates at loads of about 20lbs. Further implementations have properties that permit elongation atabout 10 lbs. Other force amounts, smaller and greater than thoseidentified also may be used. It should be noted that the tension zone112 may include substantially homogenous or substantially uniformmaterial properties along its length between the anchoring points. Inother implementations, minor interruptions in uniform properties alsoare contemplated.

In some implementations, the tension zone 112 is designed to carrytension loads, but to not carry compression loads. Accordingly, it canbe folded or rolled for packaging, and then unfolded or unrolled foruse, having properties as a non-distensible or distensible fabricmaterial.

The separable anchor pad 104 shown in FIGS. 1 and 1A includes a pad bodyportion 170 and an attachment surface 172. A biocompatible adhesivelayer 174 is disposed on the pad body portion 170 and is configured toadhere directly to a patient's skin or an inanimate surface. In someembodiments, the adhesive of the adhesive layer 174 is configured toeasily release from the patient's skin with minimal damage or sorenessafter a medical procedure is complete. In some embodiments, prior touse, the adhesive layer 174 faces a non-stick removable backing (notshown) that can be peeled away to reveal the adhesive layer 174 on thepad body portion 170.

The attachment surface 172 is configured to face away from the patient'sskin and provides an interfacing surface to releasably fasten to thesecondary anchor zone 114 of the tissue retention belt 102. Theattachment surface 172 includes a releasable fastening feature that maybe, for example, a part of a hook and loop fastening system or areleasably adhesive system. While hook and loop fastening systems aredisclosed as being used in the illustrated implementations, it iscontemplated that in further implementations alternative releasablefastening mechanisms are employed. For example, such releasablefastening systems have a greater shear strength than peel strength andmay include, but without limitation to alternative structures, magneticcouplings, specialized adhesives, ratchet teeth, directional specificfibers, among others. In the exemplary implementation shown, thefastening feature comprises hooks of a relatively rigid hook portion ofthe hook and loop fastening system. In some implementations, thefastening feature is included over substantially the entire attachmentsurface 172 of the anchor pad 104 as a plurality of hooks.

In some implementations, the anchor pad 104 is at least partiallyflexible and conforms to contours of a patient's body shape. Forexample, the anchor pad 104 is sufficiently flexible to conform about apatient's curved shoulder, neck, or about edges of mechanical structuresor other inanimate objects, such as a mattress, a bedframe, a supportstructure, or other features. It may have the rectangular shape shown,or may have other alternative shapes, such as circular, crescent, oval,triangular, or any other suitable shape. In the exemplary implementationshown, the anchor pad 104 includes rounded corners that enable theanchor pad 104 to more comfortably adhere to the patient's skin and areless likely to cause irritation. In the exemplary implementation shown,the anchor pad 104 includes a width W_(p) and a length L_(p) with thewidth W_(p) being greater than the length L_(p). In someimplementations, the width W_(p) is in the range of 5-14 inches long andthe length L_(p) is in the range of 4-8 inches long. In otherimplementations, the width W_(p) is in the range of 7-8 inches long andthe length L_(p) is in the range of 5-6 inches long. Thus, in someaspects, the anchor pad 102 has an area ranging from 20 to 112 squareinches. Other dimensions, both larger and smaller, are alsocontemplated.

Because in the implementation shown, the anchor pad 104 has a widthW_(p) greater than the width W₂ of the secondary anchor zone 114, theanchor pad 104 acts to laterally distribute loading from the secondaryanchor zone 114 along an area of adipose tissue having a greater widththan the overlap area. Further, because the attachment surface 172 ofthe anchor pad 104 includes the attachment features, which in theexample shown are hooks of a hook and loop fastener, the secondaryanchor zone 114 is disengaged from the anchor pad 104 and reattachedwith little effort in a different location on the anchor pad 104,permitting easy tension zone adjustment to an infinite number oflocations on the anchor pad 104. Naturally, this same adjustment to anyof a number of locations may be made on the secondary anchor zone 114.Still further, once the secondary anchor zone 114 is engaged to anchorpad 104, the attached adipose tissue will be held in a desired location.

The adhesive used to form the adhesive layer 174, the adhesive layer122, and the adhesive layer 142 is selected to have material propertiespermitting it to be peeled from the patient's skin after the procedureis complete by pulling a corner or edge from the skin at an angle fromthe skin within a range from about 10 to 170 degrees while maintainingskin integrity, or without damaging the skin. In some implementations,the adhesive is a body worn medical adhesive from any of a variety ofadhesive providers including 3M.

Referring to FIG. 1, the width W₂ of the secondary anchor zone 114 isshown as less than the width W_(p) of the anchor pad 104. In someimplementations, the ratio of the width W_(p) of the anchor pad 104 tothe width W₂ of the secondary anchor zone 114 is within a range of 1.5:1to 4:1. In some implementations, the ratio of the width W_(p) of theanchor pad 104 to the width W₂ of the secondary anchor zone 114 iswithin a range of 2:1 to 3.5:1. Other ratios, both larger and smallerthan those identified here also are contemplated.

The anchor pad 104 and secondary anchor zone 114 together define anoverlap area represented by the area of the secondary anchor zone 114that is selectively fastened to the anchor pad 104. FIG. 1 shows thisoverlap area having a length Lo which is the maximum length of thesecondary anchor zone 114 fastened to the anchor pad 104 and having anoverlap width Wo which is the maximum width of the secondary anchor zone114 fastened to the anchor pad 104. In FIG. 1, the overlap length Lo andthe overlap width Wo are substantially the same as the respective anchorpad length L_(p) and the tension zone width W₂. However, the overlaparea may differ from that shown and is dependent upon where thesecondary anchor zone 114 is placed on the anchor pad 104. Furthermore,it is contemplated that in alternative implementations, the width of thefiber loops is less than the width of the secondary anchor zone 114.Thus, in these implementations, the overlap area (defined as the area ofthe secondary anchor zone 114 that is selectively fastened to the anchorpad) is less than the area of the secondary anchor zone 114 thatoverlies, but does not fasten to, the anchor pad 104. In someimplementations, the ratio of anchor pad area to overlap area is withina range of 1:1 to 6:1. In other implementations, the ratio is within arange of 1.5:1 to 5:1, and in yet other implementations, the ratio iswithin a range of 2:1 and 4:1.

In some implementations, the primary anchor zone 110 and the secondaryanchor zone 114 (with or without the anchor pad 104) are selected toprovide a 135 degree closure peel strength average within a range ofabout 1-10 oz/inch width and more particularly, within a range of about1-8 oz/inch width, and more particularly about 2-6 oz/inch width. Inother implementations, they are selected to have a 135 degree closurepeel strength average within a range of about 3 oz/inch width. It iscontemplated that in high tension applications of one implementation,the 135 degree closure peel strength is approximately 32 oz/inch width.In a preferred implementation, the adhesive to skin peel strength isgreater than the closure peel strength. For example, in one aspect, theskin peel strength is at least twice as great as the closure peelstrength. In a further implementation, the hook and loop closure peelstrength is less than 50%, and preferably less than 25%, of the adhesiveto LDPE, 180 Degree peel of the anchor pad adhesive. Still further, theshear strength of the hook and loop fastening system described herein issubstantially greater than the closure peel strength. For example, theshear force applied to the tension zone/anchor pad overlap areadescribed above can be as high as 80 pounds while the hook and loopclosure peal strength at 135 degrees is less than 10 oz/inch width.Thus, in one aspect, the force needed to decouple the hook and loopfastening assembly is less than 20 oz. while the shear strength to holdtissue is at least as large as 80 pounds.

The longitudinal length L₁ of the tissue retention belt 102 is longenough to extend from a patient's abdominal region, around the patient'sshoulder or neck and back to the abdominal region. In someimplementations, the tissue retention belt 102 has a length long enoughto extend from the patient's abdominal region to an area above thepatient's head to attach to a stable structure, such as a surgical bed.The anchor pad 104 and the tissue retention belt 102 may be formed of anon-radiopaque material permitting them to be used without affectingradiology processes or treatments.

In some implementations, the secondary anchor zone 114 comprises afolding anchor portion that may be looped about a physical structure,and then reattached to itself. In such an anchor zone, one portion ofthe anchor zone may include, for example, a hook portion and anotherportion may include a loop portion. By looping the anchor portion abouta mechanical structure the hook and loop portions may connect and securethe secondary anchor zone 114 about the mechanical structure.

FIG. 4 shows an example of an obese patient laying on a hospitalsurgical table in a position for a surgical procedure, such as, forexample, a cesarean section. The procedure includes placing the patienton the operating room table per protocol, generally in supine positionwith a left lateral tilt. As shown, the patient has a pannus orabdominal apron entirely covering the lower abdomen. In order to performthe procedure, the operating physician is required to expose the lowerabdomen by displacing the pannus. The physician or other health careprovider may lift the pannus and then scrub the abdomen per hospitalpolicy with a cleanser such as alcohol or Betadine scrub. It iscontemplated, however, that in some instances, a part of or the entirepannus displacement procedure, as described below, may occur prior toscrubbing or prepping the pannus. The adhesive described above maintainsits adhesion in the presence of cleansers such as alcohol and Betadinescrub.

The removable backing 121 may be removed from the primary anchor zone110 to expose the adhesive layer 122 (FIG. 3). The primary anchor zone110 may then be applied directly to the skin on the lower abdomen sothat the adhesive layer 122 on the primary anchor zone 110 securelyadheres to the skin. If using a non-incisable primary anchor zone 110,care should be taken to not place the primary anchor zone 110 over skinintended for incision. In addition, care should be taken to arrange theprimary anchor zone 110 so that the tension zone 112 and the secondaryanchor zone 114 extend in the direction to be pulled in tension. Thatis, the tension axis 134 of the tension zone 112 should be aligned in adirection of desired tension.

FIG. 4 shows two tissue retention systems 100 with primary anchor zones110 applied to the underside of the pannus so that an upper portion ofthe primary anchor zone 110 protrudes outwardly from the folds of skin.The anchor pad 104 may, in some implementations, be applied to a desiredanchoring location. This may include removing backing material to exposethe adhesive layer 174, and then adhering the anchor pads 104 to thedesired location about the surgical room. In this exemplaryimplementation, the separable anchor pads 104 are disposed at an end ofthe surgical bed 200. In other implementations, the separable anchorpads 104 may be placed at additional locations on or about the patient.In some implementations, the separable anchor pads 104 may be disposedon the patient's shoulders. These anchor pads 104 also serve to connectto the secondary anchor zone 114 of the tissue retention belt 102 asdescribed below.

With the primary anchor zones 110 applied to the skin of the pannus, thehealthcare provider may grasp the tension zone 112 or the secondaryanchor zone 114 and pull in the direction of desired pannus movement.Accordingly, the tension zone 112 may extend along the tension axis in adirection of loading to be applied to retained tissue. The tension axisaligns with and is representative of the direction that a health careprovider desires the tissue to move. The healthcare provider maycontinue to apply tension to the tissue retention belt 102 in thedirection of desired tissue movement and by using the tissue retentionbelt 102 the healthcare provider may lift or displace the pannus to adesired position.

A healthcare provider may use the auxiliary anchor zone 130 on thetension zone 112 to provide additional adhesive support and to furtherdistribute loading over a larger contact area of the patient's skin. Theauxiliary anchor zone 130 enables a healthcare provider to customize thetechnique by using a larger adhesive contact area depending upon theneed and preference of the healthcare provider. Because healthcareproviders can choose whether or not to use the auxiliary anchor zone130, there is no need to apply adhesive layers onto the skin of thepatient when it is not necessary or desired. Because of this, removal ofthe adhesive layers from the skin can be expedited, making cleanup aftera surgical procedure more efficient, thereby reducing the overall timeof the surgical procedure. In addition, if any adjustment is desired,there may be a smaller adhesive area to be peeled free prior to makingthe adjustment. However, if the auxiliary anchor zone 130 is needed ordesired, healthcare providers can also adhere the auxiliary anchor zone130 to the patient's skin. This may be done to further distributeloading over a larger skin area to protect the patient, or may be doneduring the surgical procedure if perspiration or moisture on the skinbegins to impact adhesion of the primary anchor zone 110 during thesurgical procedure.

If the healthcare provider decides to apply the auxiliary anchor zone130, he or she may first remove the removable backing 144 and then applythe auxiliary anchor zone 130 directly to the skin so that the adhesivelayer 142 securely adheres to the skin. Then by grasping and pulling thetension zone 112 and/or the secondary anchor zone 114, the healthcareprovider may displace the pannus or other skin in the desired directionof tension.

When the displaced tissue is in a desired position, the secondary anchorzone 114 may be fixed in place to maintain the displaced tissue in thedesired position. In some implementations, the secondary anchor zone 114may attach to the separable anchor pads 104. In other implementations,the secondary anchor zone 114 may include its own adhesive layer, andmay attach directly to the patient or to other equipment within thesurgical room. For example, the secondary anchor zone 114 may attach toa mechanical structure or other inanimate object such as the bed frameor mattress, the shoulder of the patient, or other locations asdescribed herein or about the surgical room.

FIG. 5 shows the tissue retention system 100 in an assembled position,with the tissue retention belt 102 anchored to the separable anchor pad104. In the implementation shown, the primary anchor zone 110 at thedistal end of the tissue retention belt 102 is adhesively adhered to thepannus while the proximal end of the tissue retention belt 102 istensioned and attached to the separable anchor pad 104 disposed at theend of the bed. Here, as discussed above, the anchor pad 104 includes ahook material and the secondary anchor zone 114 includes a loopmaterial. Although shown in a particular location on the pannus, it iscontemplated that the primary anchor zone 110 may be placed in anydesired regions, including the supra pubic region of the body. Theshaded area 180 represents an area that is normally hidden where theskin of the pannus rests against the skin of the lower abdomen.

In some implementations, the tissue retention belt 102 does not attachto anchor pads disposed on the patient's shoulders or other bodyportion, but may extend behind the patient's neck or about the patient'sshoulder and the secondary anchor zone 114 returns and attaches to thepannus. Thus, a single tissue retention belt 102 may be used to securethe pannus.

During or while still preparing to perform the medical procedure, thelocation of the tissue retention belt 102 may be adjusted at thesecondary anchor zone 114. This is accomplished by simply detaching thesecondary anchor zone 114 from the anchor pad 104, moving the pannusand/or the secondary anchor zone 114 to the desired position, andreattaching the secondary anchor zone 114 to the anchor pad 104. In someimplementations, detaching the secondary anchor zone 114 from the anchorpad 104 is simply accomplished by pulling the secondary anchor zone 114to detach the attachment features, such as the hook and loop portions.The secondary anchor zone 114 is then re-attached at the desiredlocation. In this way, the pannus can be adjusted simply by manipulatingthe secondary anchor zone 114. Because the tissue retention belt 102includes a non-adhering contact region 132, adjustment or revision ofthe connection location of the tissue retention belt 102 may berelatively easily accomplished. For example, if the tension zone 112were adhered to the patient along its entire length, adjustment of thesecondary anchor zone 114 would also require separation of the adhesivelayer 142 of the tension zone 112 from the patient before an adjustmentcould be made.

FIGS. 6 and 7 show a side view of the patient with a pannus displaced toexpose regions of skin for surgical access. FIG. 6 shows an adhesivearea 250 including only the primary anchor zone 110. In this embodiment,the auxiliary anchor zone 130 is still covered with the removablebacking 144 and therefore not in contact with the skin. In contrast,FIG. 7 shows an adhesive area 252 including both the primary anchor zone110 and the auxiliary anchor zone 130. As can be seen, since theauxiliary anchor zone 130 forms a portion of the tension zone 112, usingthe auxiliary anchor zone 130 increases the size of the adhesion area inthe direction of the tension axis.

Once the adipose tissue is securely displaced to expose the surgicalsite, the healthcare provider may perform the medical procedure. Forexample, in one exemplary procedure, such as a cesarean section, theinitial steps of pre-positioning the adipose tissue includes exposingthe surgical site where the surgical procedure will be performed asexplained above. The incision site is then prepared. An incision, suchas a transverse incision, a midline incision, or other suitableincision, may be made in the lower abdomen. In one aspect, after makingthe incision, one or more retractors may be used to further enlarge thesize of the opening and/or to retract fat, muscle, blood vessels, andother structures below the surface of the skin. The procedure continueswith the baby being born through the opening. Any retractors used duringthe procedure are removed from the incision. In some applications, suchas child birthing, the change in the patient's abdominal size willnaturally reduce the force on the tissue retention belt. However, ifincreased tension and/or a further reduction in tension is required, theforce on primary anchor zone 110 may be modified by momentarilydisengaging the secondary anchor zone 114 and then reattaching it in analternative tensioning position while further medical steps of theprocedure are completed on the patient. For example, the placenta may bedelivered through the incised opening while the tension zones are in thealternative tensioning position. Eventually, the opening is suturedclosed. In a preferred method, once the surgical procedure is complete,the secondary anchor zone 114 may be released from its anchoring pointand the auxiliary anchor zone 130 and primary anchor zone 110 may becarefully peeled from the patient's skin.

FIG. 8 shows an alternative tissue retention system 300. Here, thetissue retention system 300 includes a tissue retention belt 302 with aprimary anchor zone 310, a tension zone 312, and a secondary anchor zone314. The primary anchor zone 310 includes many features alreadydescribed with reference to the primary anchor zone 110. As such, thedescription relating to the primary anchor zone 110 is also applicableto the primary anchor zone 310. For example, the primary anchor zone 110includes the body portion 120 and the adhesive layer 122. FIG. 8 alsoshows the removable backing 121 on the primary anchor zone 310. In thisimplementation, however, the primary anchor zone 310 is shapeddifferently than the primary anchor zone 110. Here, the primary anchorzone 310 is formed at the distal end of the tissue retention belt 306with a width that is generally the same as the width of the tension zone312. As described above, the width of the primary anchor zone 310 inthis implementation may be within the range of about 3 to 12 inches,although widths both larger and smaller are contemplated. In someimplementations, the width is within a range of about 3 to 6 inches.Other ranges are contemplated. The longitudinal length of the primaryanchor zone 310 may be selected to take into account the width of theprimary anchor zone 310 to provide a primary anchor area within a rangeof about 20 to 112 in², although larger and smaller areas arecontemplated. In some implementations, the longitudinal length of theprimary anchor zone 310 is in the range of about 4 to 10 inches,although larger and smaller longitudinal lengths are contemplated.

The tension zone 312 also includes an auxiliary anchor zone 330. Theauxiliary anchor zone 330 may include features similar to the auxiliaryanchor zone 130, and the description relating to the auxiliary anchorzone 130 may also apply to the auxiliary anchor zone 330. For example,although a slightly different shape, the auxiliary anchor zone 330includes the adhesive layer 142, the removable backing 144, and thegraspable tab 146. The tension zone 312 also includes the non-adheringcontact region 332 and the body portion 150 of the non-adhering contactregion 332.

The secondary anchor zone 314 includes many features already describedwith reference to the secondary anchor zone 114. As such, much of thedescription relating to the secondary anchor zone 114 is also applicableto the secondary anchor zone 314. In this embodiment, however, thesecondary anchor zone 314 includes an adhesive layer 316 and a removablebacking 318. Therefore, this embodiment of the tissue retention belt 302may function without a separable anchor pad. Instead, the secondaryanchor zone 314 may be adhered directly to the patient or an inanimateobject such as the surgical bed, or may be adhered to some otheranchoring structure in the surgical room. In implementations where thesecondary anchor zone 314 includes an adhesive layer, the adhesive maybe the same as that described above with reference to the primary anchorzone 110.

FIG. 9 shows one example of a side view of the tissue retention system300 of FIG. 8. As noted, the removable backing 121 of the primary anchorzone 310 may be removed to allow tissue retention belt 302 to secure tothe skin of the patient. Likewise, the removable backing 144 of theauxiliary anchor zone 330 may be removed if desired. The removablebacking 318 of the secondary anchor zone 314 may be removed to securethe proximal end of the tissue retention belt 302 to the patient or aninanimate object.

FIG. 10 shows an additional implementation of a tissue retention belt350 of a tissue retention system 348. The tissue retention belt 350 issimilar in many respects to other tissue retention belts describedherein, and for simplification, the descriptions of similar featureswill not be re-described. In this implementation, however the tensionzone 353 includes an auxiliary anchor zone 352 that extends the lengthof the tension zone 353. In this implementation, the auxiliary anchorzone 352 includes the body portion 358, an adhesive layer 360, and aremovable backing 362. In this implementation, the adhesive layer 360 ofthe auxiliary anchor zone has a lower bond strength than the adhesive atthe primary anchor zone 310 and the secondary anchor zone 314. Theremovable backing 362 may include perforations or cuts 364 thatdistinguish one anchor zone from another, making each backingindependently removable.

FIG. 11 introduces another tissue retention system referred to herein bythe numeral 400 and comprised of a tissue retention belt 402. The tissueretention belt 402 in this embodiment includes a primary anchor zone410, a tension zone 412, and a secondary anchor zone 414. The primaryanchor zone 410 and the secondary anchor zone 414 may have featuressimilar to those previously described, and they will not be re-describedhere. In this implementation, the tension zone 412 comprises a pluralityof auxiliary anchor zones referenced herein by the numerals 420 a, 420b, 420 c, 420 d, 420 e, 420 f, and 420 g. This implementation showsseven auxiliary anchor zones together extending the entire distance fromthe primary anchor zone 410 to the secondary anchor zone 414. Otherimplementations have fewer than seven auxiliary anchor zones, or morethan seven auxiliary anchor zones. Some implementations have two, three,or four auxiliary anchor zones. In some implementations, the auxiliaryanchor zones extend the entire distance between the primary anchor zone410 in the secondary anchor zone 414 as shown in FIG. 11, while in otherimplementations, the auxiliary anchor zones extend only a part of thedistance between the primary anchor zone 410 and the secondary anchorzone 414. In some implementations, auxiliary anchor zones are disposedadjacent the primary anchor zone 410, and any non-adhering contactregion that may be included in the tension zone may be disposed adjacentthe secondary anchor zone 414.

In the example shown, the tissue retention belt 402 includes acontinuous integrated body portion 422, and includes distinct adhesivelayers and backing materials. Here, the adhesive layers and backingmaterials are sliced with cuts 446 so as to be distinct from one anotherand independently removeable. In some implementations, the cuts 446 areperforations that promote independent removal of the removable backingfrom one anchor zone and separating the removable backing from adjacentanchor zones. In such embodiments, the removable backing may befrangible in order to be easily torn or separated from adjacentremovable backing.

Other implementations include a continuous integrated body portion 422,and a continuous integrated adhesive layer formed of the adhesive layers442 a-442 g. In such implementations, the removable backing may befrangible by being precut, or may include perforations or other featuresthat enable user to distinguish between the primary anchor zone 410 andany of the plurality of auxiliary anchor zones 420, and the secondaryanchor zone 414, and remove the backing 444 a-444 g one anchor zone at atime without removing the backing of adjacent anchor zones as desired.

In use, a medical professional may expose the adhesive layers of theprimary anchor zone 410 and the secondary anchor zone 414, and maychoose to expose one or more auxiliary anchor zones 420 depending uponfactors considered by healthcare providers. In some implementations, thefactors may include the size of the patient, the weight of the patient,how many tissue retention belts are in use, the application, thesurgical technique to be used, preference of the operating healthcareprovider, and other factors.

FIG. 12 illustrates another implementation of a tissue retention system500 comprised of a tissue retention belt 502. The tissue retention belt502 includes a primary anchor zone 510 a tension zone 512 and asecondary anchor zone 514. The primary anchor zone 510 and the secondaryanchor zone 514 may have features similar to those previously described,and therefore they will not be re-described here. In thisimplementation, the tension zone 512 may include an auxiliary anchorzone 516 that may extend the distance between the primary anchor zone510 and the secondary anchor zone 514. The auxiliary anchor zone 516 maybe formed with the same integrated body portion as the primary anchorzone 510 and the secondary anchor zone 514. In other implementations,body portions may be permanently affixed to each other via sewing,ultrasonic welding, adhesion, or using other methods. In thisimplementation, the auxiliary anchor zone 516 may include different bondstrength or tension characteristics. These may be due to a number offactors including, a different adhesive, a different amount of adhesive,an integrated or mixed area of adhesion, or other factors. As such, thebond strength of the primary anchor zone 510 and the secondary anchorzone 514 may be different than the bond strength of the auxiliary anchorzone. The tension zone 512 includes a removable backing 520 that coversthe auxiliary anchor zone 516 and allows a healthcare provider to decidewhen to use the auxiliary anchor zone.

FIG. 13 shows one example of an adhesive pattern 550 that may form apart of any of the auxiliary anchor zones described herein. In thisimplementation, FIG. 13 shows an end of a tissue retention belt 544 withan anchor zone 546 adjacent a non-adhesive tension zone 548. The anchorzone 546, which represents any anchor zone in any implementation herein,includes alternatingly disposed rows of an adhesive area 552 and anon-adhesive area 554. In some implementations, the auxiliary anchorzones include such alternating adhesive pattern, while the primaryanchor zone and the secondary anchor zone are completely covered by acontinuous adhesive. This would create a difference in the bond strengthof the auxiliary anchor zone and the primary and secondary anchor zones.In other implementations, all of the anchor zones, including theprimary, the secondary, and the auxiliary anchor zones have continuousadhesive layers across their surfaces. In other implementations, theprimary and secondary anchor zones also include adhesive in analternating pattern. In some implementations, the primary anchor zoneand the secondary anchor zone have the same bond strength, while inother implementations, their bond strength differs. In someimplementations, the primary anchor zone has a greater bond strengththan the secondary anchor zone, and the secondary anchor zone has agreater bond strength than the auxiliary anchor zone. In otherimplementations, the secondary anchor zone has a lower bond strengththan the auxiliary anchor zone and the primary anchor zone. In someimplementations, instead of having rows of an adhesive 552 and anon-adhesive area 554, the tissue retention belt includes rows of anadhesive with a first bond strength and an adhesive with a second bondstrength. In yet other embodiments, the pattern includes adhesives witha height difference between rows. For example, the adhesive area 552 mayhave an elevation different than the non-adhesive area 554. Althoughshown with rows, other embodiments include adhesive droplets or shapedpatches of adhesive and non-adhesive areas. In some implementations, theanchor zone includes an adhesive gradient with a greater bond strengthat one portion of the anchor zone and lower bond strength at theopposing portion of the anchor zone. This may include using a largeroverall adhesive area that may taper toward an area with a smalleradhesive area. For example, the rows in FIG. 13 may be wider at one endand smaller at the other to provide a gradient in bond strength.

FIG. 14 shows an exemplary implementation of a tissue retention system580 comprised of a tissue retention belt 582 in the form of a belt roll.The belt roll may contain sufficient material to form a plurality oftissue retention belts. In some examples, the belt roll may have a totallinear length in the range of 12 feet to 50 feet, although both largerand smaller ranges are contemplated. The belt roll may be formed ofmaterial as described herein and include the body portion 584, theadhesive layer 586, and the removable backing 588. In the embodimentshown, at least the body portion 584 is integrated. Depending on theimplementation, the adhesive layer 286 may also be integrated. Theremovable backing 588 may include perforations or cuts that distinguishone anchor zone from another, making each independently removable. Theremovable backing may form the skin-contacting, non-adhesive surface ofthe tissue retention belt when the auxiliary anchor zones are notadhered to the patient. In some implementations, each of the removablebackings 588 includes a tabbed portion that can easily be grasped forsimple removal from the adhesive. In some implementations, the unrolledbelt roll may form a tissue retention belt as shown in FIG. 11.

In use, a health care provider may unroll a tissue retention belt 582 ofa desired length, thereby forming the tissue retention belt. He or shemay then cut or tear a desired length from the roll. The distal portionof the tissue retention belt may be referred to as a primary anchorzone, and a proximal portion of the tissue retention belt 582 may bereferred to as a secondary anchor zone. The plurality of auxiliaryanchor zones between the primary and secondary anchor zones may form thetension zone. Until the removable backing is removed, the auxiliaryanchor zones will not attach to a patient's skin. However, if desiredbased on the factors described herein, a health care provider determinesto use an auxiliary anchor zone, then he or she may remove the removablebacking to expose the adhesive layer of the auxiliary anchor zone.

In some surgical implementations, the belt roll may be disposed in asurgery room allowing healthcare providers to unroll and cut or tear adesired length from the belt roll. In other implementations, the beltroll may include a plurality of distinct and precut tissue retentionbelts. Accordingly, a user may unroll the belt roll to obtain a precutlength, while remaining tissue retention belts may be maintained in rollform for storage.

Although described with reference to exposing the lower abdomen, itshould be apparent that a similar method may be used to expose the groinregion when access is required. This may be useful with some patientsfor hysterectomies and normal vaginal births of obese patients, forexample. Still further, the tissue retention system may be used for longterm treatments to expose tissue to speed healing and/or preventinfection. In other implementations, the first anchor zone may beattached to the underside of the patient's breast to support the adiposetissue and maintain it in a desired position. This is useful forexample, in applications requiring surgical access or radiologicaltests. In some examples, the tissue retention system may be used foroncology purposes, including radiation treatment. In someimplementations, the tissue retention system may be used on a patient'sthigh in order to move the adipose tissue to provide access for amedical procedure. This may provide better visualization during repairor surgery of the groin, perineum, vaginal vault, or other areas needingbetter visualization under the adipose tissue. Also, the tissueretention system 100 also can facilitate access to the femoral regionfor all types of cardiovascular procedures, ranging from angioplasty tousing a Foley catheterization and to any type of thoracic surgery thatrequires catheterization of the femoral artery. In otherimplementations, the primary anchor zone may be attached to a patient'sright buttocks and a second anchor pad 104 is attached to the patient'sleft buttocks to displace the buttocks and expose the rectum. This mayprovide better visualization during, for example, hemorrhoid surgery orrepair of the anus, among other procedures.

In yet other implementations, the patient is placed in a supine positionwith the patient's torso elevated higher than the patient's head. In sodoing however, the weight of the pannus, which on some obese patientsmay be more than one hundred pounds, may shift to at least partially lieon the patient's lungs, rendering breathing difficult or impossible. Thetissue retention system disclosed herein however, may be used toalleviate some of the weight on the lungs by maintaining the adiposetissue, such as the pannus, in its more natural location.

While the examples set forth herein primarily describe attaching theanchor pads directly to the skin, in some alternatives, the anchor padsattach to surgical drapes over an incision. Accordingly, in theseinstances, the anchor pads may not attach directly to the skin, butattach to the surgical drapes adhered to the skin.

FIGS. 15 and 16 are flowcharts illustrating an exemplary method 600 ofretaining patient tissue in a desired position. The method may begin bypreparing the patient for the medical procedure. This may includeplacing the patient on the operating room table per protocol. At block602 the health care provider provides a tissue retention belt. In someimplementations, this may include removing the tissue retention beltfrom packaging. In other implementations, this may include removing adesired length of a tissue retention belt from a tissue retention roll.Removing the tissue retention belt from a tissue retention roll mayinclude tearing or cutting a desired length from the tissue retentionroll. The tissue retention belt may be any of the tissue retention beltsdescribed herein.

At block 604, the health care provider may expose the adhesive surfaceof the primary anchor zone by removing the backing material. At block606, the health care provider may adhesively adhere the primary anchorzone to the patient's skin. This may include applying the exposedadhesive surface directly to the skin on the lower abdomen to securelyadhere the primary anchor zone to the skin. Care should be taken toalign the tension zone in the desired direction of tissue movement sothat the tension axis extends in a direction acceptable to the healthcare provider and when the tissue is displaced, provides the desiredaccess for the surgical procedure.

At block 608, the health care provider may expose the adhesive surfaceof the auxiliary anchor zone by removing the non-adhesive backing of theauxiliary anchor zone. This may include making a determination aboutwhether to employ the auxiliary anchor zone of the tissue retentionbelt. The determination may be based on any number of factors includingfor example, health care provider preference, the weight of the patient,the length of the procedure, the type of the procedure, and otherfactors described herein.

With the auxiliary anchor zone adhesive surface exposed, at block 610,the health care provider may adhesively adhere the auxiliary anchor zoneto the patient. This may distribute skin loading onto both the primaryanchor zone and the auxiliary anchor zone.

At block 612, the health care provider may pull the tissue retentionbelt in tension in the direction of the tension axis. This may displacetissue in the desired direction to provide greater access to a bodyregion of the patient needing treatment. Since the health care providermay initially anchor one end of the tissue retention belt, in someimplementations, only a single health care provider is needed to pull onthe tension zone or the secondary anchor zone to displace the tissue tothe desired location.

At block 614, the health care provider may expose the adhesive surfaceon the secondary anchor zone or expose the adhesive surface on theanchor pad. In some implementations, this may include removing theseparable backing from the secondary anchor zone. In implementationsemploying the separable anchor pad, this may include removing thebacking from the anchor pad to expose the adhesive surface of the anchorpad. In such implementations, the anchor pad is then secured at ananchoring location. This may be anywhere about the surgical site and mayinclude locations on the patient or off the patient. In someimplementations, the anchor pad may be secured to the patient'sshoulder. In other implementations, the anchor pad may be secured to amechanical structure forming an in animate object adjacent the patient.This may include portions of the surgical room bed or other mechanicalstructures about the patient.

At block 616, the health care provider secures the secondary anchor zoneat an anchor location spaced apart from the primary anchor location sothat the tension zone is tautly connected in tension along the tensionaxis. This may include securing the adhesive surface of the secondaryanchor zone to an anchoring location. The location may be any of thosedescribed herein including the patient or inanimate objects ormechanical structures disposed about the patient. Block 616 may alsoinclude securing the secondary anchor zone to the previously placedanchor pad. In implementations using hook and loop fastening mechanisms,this may simply require moving the secondary anchor zone over the anchorpad so that they touch and connect.

With the tissue retention belt properly securing the adipose tissue in adesired position, the surgeon may then perform the procedure. When theprocedure is complete, the health care provider may remove the tissueretention belt by un-attaching the secondary anchor zone from either theanchor pad, the patient, or the mechanical structure to which it isattached. It may also include carefully peeling the auxiliary anchorzone and the primary anchor zone from the patient's skin.

In some implementations, securing the anchor zone at an anchor locationspaced apart from the first anchor location includes looping the secondanchor zone around a physical structure, such as a bed frame, and thenattaching the anchor zone to itself. For example, this may includelooping a hook portion about a mechanical structure and then connectingit to a loop portion.

FIG. 16 is a flowchart showing a method 650 of revising a patient tissueretention system. The method may begin after the tissue retention systemhas been properly implemented according to the method shown in FIG. 15.FIG. 16 is a method that may be followed when the healthcare providermade a determination to not adhere the auxiliary anchor zone to thepatient. In FIG. 16, the tissue retention system may be adjusted orrevised by, at block 618, un-attaching the secondary anchor zone fromits anchor location. This may include un-attaching the secondary anchorzone from the anchor pad, or may include peeling the secondary anchorzone from the patient's skin, or an inanimate object, such as amechanical structure to which it may be attached. Keeping the tensionzone taught, the health care provider may grasp the backing of theauxiliary anchor zone and peel it from the adhesive surface of theauxiliary anchor zone. This exposes the adhesive surface which may thenbe brought into contact against the skin. At block 620, after adhesivelyadhering the auxiliary anchor zone, the secondary anchor zone may bere-attached as desired.

In addition, the tissue retention system may be a part of a kit. In someimplementations, the kit may include a pouch or tray in which a tissueretention belt and an anchor pad may be stored or placed for use. Insome implementations, the kit includes one tissue retention belt and twoanchor pads. In some implementations, a second pouch or tray (not shown)may be provided within the pouch or tray and may contain therein one ormore anchor pads. This may keep the tissue retention belt and pads fromattaching to each other during storage or shipping and provides easieraccess to an attending health care provider. Other configurations of theabove are also contemplated.

In some implementations, the kit may be assembled for specific surgicalprocedures. For example, a child birthing kit may include one or moreanchor pads, one or more tissue retention belts, a cotton tipapplicator, bulb syringe, pads, gauze, suction tubing, cord clamp, and aFoley catheter. It also may include a drape, table cover, gowns, basins,bowls, laps, absorbent towels, disposal bags, mayo stand cover, Bovie,sterile towels, light handle covers, labels, marking pen, anddrapes/pouch, among other items. The kit also may include thesefollowing items that may be used during the procedure: a drape, tablecover, gowns, 2 basins, laps, 1 disposal bag, needle counter, 1 six inchcotton tip applicator, tray organizer, 1 bulb syringe, 1 mayo standcover, 1 CSR, wrap×2, Bovie (cauterizing unit), 1 pitcher (1200 ml),sterile towels, 2 pads, 1 gauze 18″×18″, 2 light handle covers, 4×4raytex-10, 1 absorbent towel, 1 blue bowl, suction tubing, labels, 1-CSRpoly-back, 2 #20 blades, cord clamp, marking pen, suction equipment,drapes/pouch, Foley catheter. It also may include the physician'spreference for sutures, dressing, staples, JP drains. A discussion of anexemplary method and/or additional items that may be included in the kitis provided in U.S. Pat. Nos. 4,880,418, 5,676,672, and 6,102,924, allincorporated herein in their entirety by reference.

In another example, a femoral catheterization kit may include one ormore anchor pads, one or more tissue retention belts, a needle sized topuncture the patient's skin and enter the femoral artery, and a flexiblehollow tube such as a catheter for threading through the femoral artery.A discussion of an exemplary method and additional items that may beincluded in the kit is provided in U.S. Pat. No. 4,355,026, incorporatedherein in its entirety by reference.

In yet another example, a hysterectomy kit may include one or moreanchor pads, one or more tissue retention belts, pads, gauze, cotton tipapplicator, suction tubing, and a Foley catheter. It also may include adrape, table cover, a gown, a basin, a bowl, a lap, absorbent towels,disposal bags, mayo stand cover, Bovie, sterile towels, light handlecovers, labels, marking pen, drapes/pouch. The kit also may includethese following items that may be used during the procedure: a drape,table cover, gowns, 1 mayo stand cover, 2 light handle covers, suctionequipment, irrigation, Bovie (cauterizing unit), laps, 1 disposal bag,sponges, absorbent towels. Graspers & dissectors: atraumatic graspers,soft bowel clamps, Maryland dissectors, scissors, needle holders,bipolar forceps and cord, endoloop, tissue morecellator for largeuterus. Vaginal instrument table: single tooth tenaculum, Alis graspers,dilators, uterine manipulator, Cohen cannula, speculum, Foley catheter.If doing laparoscopic hysterectomy, the kit also may include 10 mm, 0degree laparoscope 3 sizes (2-3 mm, 5 mm, 10 mm), and trocars. It mayalso include the physician preference for suture, dressing, and staples.Other kits and uses also are contemplated.

While providing many advantages over known systems, the tissue retentionsystem disclosed herein is particularly useful on obese patients becauseit may be effectively used without wrapping around a portion of thepatient. For example, it may be entirely applied and used withoutlifting of limbs, the head, the torso, or legs. It can be applied andused entirely from one side of the patient, such as the patient's frontside or the patient's back side. Other advantages, benefits, and usesare described in U.S. Pat. No. 9,408,741, incorporated herein byreference in its entirety.

Applicants note that the procedures disclosed herein are merelyexemplary and that the systems and method disclosed herein may beutilized for numerous other medical processes and procedures. Althoughseveral selected implementations have been illustrated and described indetail, it will be understood that they are exemplary, and that avariety of substitutions and alterations are possible without departingfrom the spirit and scope of the present invention, as defined by thefollowing claims.

We claim:
 1. A tissue retention belt for maintaining tissue in aposition that permits access to a body portion of a patient for amedical procedure, comprising: an elongate flexible body having aproximal region, a distal region, and a tension zone between saidproximal region and said distal region, said proximal region comprisingat a lower surface thereof a first attachment surface having a firstattachment feature, said distal region comprising at a lower surfacethereof a second attachment surface having a second attachment feature,and said tension zone comprising a non-adhering contact region includinga layer of material attached to said tension zone, said layer ofmaterial having a non-adhesive lower surface without attachment featuresconfigured so as to not adhere to skin of said patient or attach to aninanimate object.
 2. The tissue retention belt of claim 1, wherein oneof said first attachment feature or said second attachment featurecomprises an adhesive.
 3. The tissue retention belt of claim 2, whereinsaid first attachment feature and said second attachment feature eachcomprise said adhesive.
 4. The tissue retention belt of claim 1, whereinone of said first attachment feature or said second attachment featurecomprises one of a hook and loop portion of a first hook and loopfastener.
 5. The tissue retention belt of claim 4, wherein the other ofsaid first attachment feature or said second attachment featurecomprises an adhesive.
 6. The tissue retention belt of claim 1, whereinsaid layer of material is removably attached to said tension zone. 7.The tissue retention belt of claim 1, wherein said elongate flexiblebody monolithically comprises said proximal region, said distal region,and said tension zone.
 8. The tissue retention belt of claim 7, whereinsaid tension zone is configured to elongate either elastically orin-elastically.
 9. The tissue retention belt of claim 1, wherein saidtension zone extends the full distance between said proximal region andsaid distal region.
 10. The tissue retention belt of claim 1, whereinsaid tension zone further comprises an auxiliary zone.
 11. The tissueretention belt of claim 10, wherein said auxiliary zone includes a lowersurface comprising an auxiliary adhesive.
 12. The tissue retention beltof claim 11, wherein said auxiliary zone further comprises a removablebacking covering said auxiliary adhesive, said removable backingcomprising a non-adhesive surface configured to face skin of saidpatient.
 13. The tissue retention belt of claim 12, wherein said tensionzone has a length and said auxiliary zone extends the length of saidtension zone.
 14. The tissue retention belt of claim 1, wherein saiddistal region has a first width and said tension zone has a second widthsubstantially the same as said first width.
 15. The tissue retentionbelt of claim 1, wherein said elongate flexible body has a length, saidbody having a relatively constant width of parallel edges over thelength of said elongate flexible body.
 16. A tissue retention system,comprising: a first anchor pad comprising a first adhesive surface, thefirst adhesive surface being configured to adhere to a first locationsurface, an opposing first pad attachment surface facing away from thefirst adhesive surface and including one of a hook and loop portion of afirst hook and loop fastener, and a first backing material removablyadhered to said first adhesive surface; and a tissue retention belt inaccordance with claim 1, wherein one of said first attachment feature orsaid second attachment feature comprises the other of a hook and loopportion of said first hook and loop fastener.
 17. The tissue retentionsystem of claim 16, further including a second anchor pad comprising asecond adhesive surface, the second adhesive surface being configured toadhere to a second location surface, an opposing second pad attachmentsurface facing away from the second adhesive surface and including oneof a hook and loop portion of a a hook and loop fastener, and a secondbacking material removably adhered to said second adhesive surface. 18.The tissue retention system of claim 16, wherein said tissue retentionbelt further comprises an auxiliary zone.
 19. The tissue retentionsystem of claim 18, wherein said auxiliary zone forms a part of saidtension zone of said tissue retention belt.